An interventional study of Folic acid and Placebo in Diabetic Nephropathies and Hyperhomocysteinemia, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-19.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Treatment
The development of diabetic nephropathy has been linked to several genetic polymorphisms, including those related with homocysteine metabolism such as the methylenetetrahydrofolate reductase (MTHFR)and the cystathionine-beta-synthase genes. Such alterations are associated with hyperhomocysteinemia, which is a known independent risk factor for the development of endothelial dysfunction and cardiovascular disease.
In the Mexican population there is a high prevalence of the C677T MTHFR mutation. The investigators performed this study to evaluate the prevalence of this polymorphism in type 2 diabetic patients with diabetic nephropathy compared with type 2 diabetic patients without nephropathy, besides evaluating the relationship of hyperhomocysteinemia with endothelial dysfunction and microalbuminuria before and after the administration of folic acid. We proposed that the endothelial dysfunction caused by the hyperhomocysteinemia could be reversed after the administration of folic acid.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's enrollment of 40 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Administration of an oral placebo pill
Drug: Placebo
Administration of oral folic acid
Drug: Folic acid
Administration of a daily tablet containing 5 mg of folic acid for 4 months.
Administration of an oral placebo pill
Change in albumin excretion rate
Time frame: Four months
Change in serum homocysteine, thrombomodulin and von Willebrand factor.
Time frame: Four months.
The record gives a start of Jan 2004, a primary completion of Dec 2005 and a completion of Dec 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Folic Acid
Hospital Universitario Dr. Jose E. Gonzalez